Satisfaction and Interest Strong for Remote Trials, Study Finds

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by Patricia Inácio, PhD |

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People who took part in remote, video-conducted clinical trials for Parkinson’s disease reported high levels of satisfaction and interest in participating in future studies with remote video visits, scientists report.

Three such trials showed that recruitment was feasible and enrolled participants were geographically dispersed — from across dozens of U.S. states and a Canadian province — but with a poor racial or ethic mix (mostly whites). These findings suggest a need to tweak the current recruitment process to enroll a more diversified group, particularly Blacks and Hispanics, the team noted.

The study “Recruitment for Remote Decentralized Studies in Parkinson’s Disease” was published in the Journal of Parkinson’s Disease.

In-person clinical trials are affected by factors that limit patient recruitment, ranging from a reliance on clinicians with hectic schedules to distant trial sites. Travel can be particularly constraining for people with Parkinson’s disease, given its various and progressive motor and non-motor symptoms.

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Remote trials — in which visits can be conducted by video and data obtained directly from patients — offer a glimpse into a potential direction for clinical research.

While still relatively new, remote trials are gaining in interest, greatly boosted by the COVID-19 pandemic.

Their recruitment process, however, is different from that of in-person trials, the researchers noted, raising questions as to how best to identify and enroll participants.

A team led by researchers at the University of Rochester Center for Heath + Technology (CHeT) examined the recruitment processes and outcomes of three independent Parkinson’s trials conducted remotely: the Fox Insight Validation Effort (FIVE), the Virtual Assessment of LRRK2 carriers to Optimize Research in Parkinson’s disease (VALOR-PD), and the Assessing Tele-Health Outcomes in Multi-year Extensions of Parkinson’s Disease trials (AT-HOME PD).

FIVE, sponsored by The Michael J. Fox Foundation, was a clinical study designed to validate online self-reporting as a way of collecting health information directly from participants. It enrolled 45,000 people, with and without Parkinson’s disease, and over two video visits collected information regarding motor function, cognition, and quality of life, among other measures.

VALOR-PD is an ongoing study in people carrying a genetic variant called G2019S in the LRRK2 gene, which has been shown to increase the risk for Parkinson’s disease. Participants enrolled were given genetic testing through the 23andMe and chose to participate in clinical research.

AT-HOME PD is a two-year study following patients who completed two Phase 3 studies, the STEADY-PD III (NCT02168842) and the SURE-PD3 (NCT02642393).

In total, the three studies enrolled 706 participants across 45 U.S. states and one Canadian province. A similar enrollment target covering such a vast geographical area for a conventional trial would require multiple and dispersed study sites, the researchers noted.

At least a third of participants across the studies — range 30.3–42.9% — lived in areas of the U.S. with few primary care providers, referred to as Health Professional Shortage Areas.

Participants were mostly white (over 95%) and with higher levels of education (over 90% with more than a high school education).

Almost all participants across the three studies (over 97%) said they were highly satisfied with the video visits. The most common concern related to confidentiality, which was reported by a minority of these people (13.1% in total).

Most also reported an interest in future observational (98.5–99.6%) and interventional (76.1–87.6%) studies with remote video visits.

“Compared with studies with all in-person visits, the majority of those willing to participate in future research were more interested in participating in research studies with video visits,” the researchers wrote.

They concluded that “recruitment of large, geographically dispersed remote cohorts from a single location is feasible,” and that the “interest in participation in future remote decentralized PD [Parkinson’s disease] studies is high.”

However, “the three studies examined here failed to recruit a racially, ethnically, or educationally diverse sample of participants,” the researchers added, and efforts are needed to “develop best recruitment strategies, particularly in the recruitment of Black and Hispanic/Latino participants.”

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